Interstitial Lung DiseasesNANOPINCT02549248
Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology
An observational study of Interstitial Lung Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Diseases
- What is being tested?
- BAL, BW and EAC
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * " Test group ": patients suffering from idiopathic interstitial lung diseases including sarcoidosis and idiopathic pulmonary fibrosis. * " Control group ": patients suffering from interstitial lung diseases of known aetiologies, such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.
Who may be able to join
- Patients with an interstitial lung disease assessed on clinical signs and CT scan, requiring a flexible bronchoscopy with a broncho-alveolar lavage.
- These patients suffer from:
- Idiopathic interstitial lung diseases such as idiopathic pulmonary fibrosis or sarcoidosis OR
- Interstitial lung diseases of known aetiologies such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.
- Written consent
Who cannot join
- Flexible bronchoscopy or BAL not possible.
- Pregnant women
- Patients under legal protection.
- Patients with contagious disease (HIV infection, tuberculosis, viral hepatitis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study
Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.
- Conditions
- Interstitial Lung Diseases
- Being tested
- BAL, BW, EAC, blood specimen, Urine specimen
- Keywords
- Interstitial Lung Diseases, nanoparticles, lung, broncho-alveolar lavage, bronchial washings
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALOther
Patients with idiopathic and non idiopathic interstitial lung diseases
BWOther
Patients with idiopathic and non idiopathic interstitial lung diseases
EACOther
Patients with idiopathic and non idiopathic interstitial lung diseases
blood specimenOther
Patients with idiopathic and non idiopathic interstitial lung diseases
Urine specimenOther
Patients with idiopathic and non idiopathic interstitial lung diseases
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic interstitial diseases | " Test group ": patients suffering from idiopathic interstitial lung diseases including sarcoidosis and idiopathic pulmonary fibrosis.
Nanoparticles (NP) loads will be measured on Bronchoalveolar lavages (BAL), bronchial washings (BW), exhaled air condensates (EAC), blood specimen and urine specimen. Receives: Other: BAL; Other: BW; Other: EAC; Other: blood specimen; Other: Urine specimen | |
| Non idiopathic intertitial diseases | " Control group ": patients suffering from interstitial lung diseases of known aetiologies, such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.
Nanoparticles (NP) loads will be measured on Bronchoalveolar lavages (BAL), bronchial washings (BW), exhaled air condensates (EAC), blood specimen and urine specimen. Receives: Other: BAL; Other: BW; Other: EAC; Other: blood specimen; Other: Urine specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
NP load
The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis.
Analysis: The presence of NP will be assessed by dynamic light scattering (DLS). The elemental compositions of both the particulate (pellet) and the soluble (supernatant) fractions of each sample will be measured by means of inductively coupled plasma optical emission spectroscopy (ICP-OES). The samples for which DLS and ICP-OES corroborated a relatively stronger NP load will be observed under transmission electron microscopy (TEM) and field-emission electron microscopy (FESEM).
Measured: day 1
Secondary outcomes (3)
Correlation between NP load in the lung and observed lung interstitial diseases
The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis.
The accurate diagnosis of the disease will be determined in accordance to the latest international guidelines, including the past history of each patient, the
professional courses with focus on potential NP exposure, environmental studies, tobacco or drug use and exhaustive research of collagen or vascular diseases.
Measured: Day 1
Correlation between NP load in the lung and NP load in blood specimen
The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis.
Measured: Day 1
Correlation between NP load in the lung and NP load in urine specimen
The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel VERGNON, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549248
- Sponsor's protocol ID
- 1008122
- Acronym
- NANOPI
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Marie-Desvergne C, Dubosson M, Leclerc L, Campo C, Bitounis D, Forest V, Pourchez J, Cottier M, Vergnon JM, Tarantini A, Chamel-Mossuz V. Characterization of the elemental and particle load of patient exhaled breath condensate and comparison with pulmonary lavages. J Breath Res. 2022 Dec 15;17(1). doi: 10.1088/1752-7163/aca697.
PubMed 36541529Forest V, Pourchez J, Pelissier C, Audignon Durand S, Vergnon JM, Fontana L. Relationship between Occupational Exposure to Airborne Nanoparticles, Nanoparticle Lung Burden and Lung Diseases. Toxics. 2021 Aug 30;9(9):204. doi: 10.3390/toxics9090204.
PubMed 34564355
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study
- ClinicalTrials.gov ID
- NCT02549248
- Acronym / sponsor ID
- NANOPI / 1008122
- Conditions
- Interstitial Lung Diseases
- Keywords
- Interstitial Lung Diseases, nanoparticles, lung, broncho-alveolar lavage, bronchial washings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic interstitial diseases | – | Other: BAL, Other: BW, Other: EAC, Other: blood specimen, Other: Urine specimen" Test group ": patients suffering from idiopathic interstitial lung diseases including sarcoidosis and idiopathic pulmonary fibrosis. Nanoparticles (NP) loads will be measured on Bronchoalveolar lavages (BAL), bronchial washings (BW), exhaled air condensates (EAC), blood specimen and urine specimen. |
| Non idiopathic intertitial diseases | – | Other: BAL, Other: BW, Other: EAC, Other: blood specimen, Other: Urine specimen" Control group ": patients suffering from interstitial lung diseases of known aetiologies, such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions. Nanoparticles (NP) loads will be measured on Bronchoalveolar lavages (BAL), bronchial washings (BW), exhaled air condensates (EAC), blood specimen and urine specimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * " Test group ": patients suffering from idiopathic interstitial lung diseases including sarcoidosis and idiopathic pulmonary fibrosis. * " Control group ": patients suffering from interstitial lung diseases of known aetiologies, such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.
Key inclusion criteria (5 listed)
- Patients with an interstitial lung disease assessed on clinical signs and CT scan, requiring a flexible bronchoscopy with a broncho-alveolar lavage.
- Idiopathic interstitial lung diseases such as idiopathic pulmonary fibrosis or sarcoidosis OR
- Interstitial lung diseases of known aetiologies such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.
- Written consent
Key exclusion criteria (4 listed)
- Flexible bronchoscopy or BAL not possible.
- Pregnant women
- Patients under legal protection.
- Patients with contagious disease (HIV infection, tuberculosis, viral hepatitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BALPatients with idiopathic and non idiopathic interstitial lung diseases | Other | Idiopathic interstitial diseases, Non idiopathic intertitial diseases |
| BWPatients with idiopathic and non idiopathic interstitial lung diseases | Other | Idiopathic interstitial diseases, Non idiopathic intertitial diseases |
| EACPatients with idiopathic and non idiopathic interstitial lung diseases | Other | Idiopathic interstitial diseases, Non idiopathic intertitial diseases |
| blood specimenPatients with idiopathic and non idiopathic interstitial lung diseases | Other | Idiopathic interstitial diseases, Non idiopathic intertitial diseases |
| Urine specimenPatients with idiopathic and non idiopathic interstitial lung diseases | Other | Idiopathic interstitial diseases, Non idiopathic intertitial diseases |
Primary outcome
NP load
Time frame: day 1
The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis. Analysis: The presence of NP will be assessed by dynamic light scattering (DLS). The elemental compositions of both the particulate (pellet) and the soluble (supernatant) fractions of each sample will be measured by means of inductively coupled plasma optical emission spectroscopy (ICP-OES). The samples for which DLS and ICP-OES corroborated a relatively stronger NP load will be observed under transmission electron microscopy (TEM) and field-emission electron microscopy (FESEM).
3 secondary outcomes
Correlation between NP load in the lung and observed lung interstitial diseases
Time frame: Day 1
Correlation between NP load in the lung and NP load in blood specimen
Time frame: Day 1
Correlation between NP load in the lung and NP load in urine specimen
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Derived from this study: PubMed 36541529Marie-Desvergne C, Dubosson M, Leclerc L, Campo C, Bitounis D, Forest V, Pourchez J, Cottier M, Vergnon JM, Tarantini A, Chamel-Mossuz V. Characterization of the elemental and particle load of patient exhaled breath condensate and comparison with pulmonary lavages. J Breath Res. 2022 Dec 15;17(1). doi: 10.1088/1752-7163/aca697.
- Derived from this study: PubMed 34564355Forest V, Pourchez J, Pelissier C, Audignon Durand S, Vergnon JM, Fontana L. Relationship between Occupational Exposure to Airborne Nanoparticles, Nanoparticle Lung Burden and Lung Diseases. Toxics. 2021 Aug 30;9(9):204. doi: 10.3390/toxics9090204.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel VERGNON, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NP load (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549248, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.